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CHGE71TS3 Millipore Express® SHC Cartridge Filter 10 in. 0.5/0.2 µm Code 7 Silicone

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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CHGE71TS3
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberCHGE71TS3
      Trade Name
      • Millipore Express®
      DescriptionMillipore Express® SHC Cartridge Filter 10 in. 0.5/0.2 µm Code 7 Silicone
      References
      Product Information
      HS Code8421 29 90
      Device ConfigurationCartridge
      Maximum Inlet Pressure, bar (psi)Forward - 7 bar (100 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 1.0 bar (15 psi) @ 135 °C; Reverse - 2.07 bar (30 psi) @ 25 °C; 0.07 bar (1 psi) @ 135 °C
      Cartridge CodeCode 7
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaMillipore Express® SHC
      Sterilization25 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C and 0.35 bar (5) or 3 forward SIP cycles of 30 min @ 135 °C and 1 bar (15 psid); 25 autoclave cycles of 60 min @ 126 °C
      Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.5 / 0.2 µm
      Air Diffusion at 23 °C≤28.2 mL/min @ 2.8 bar (40 psig) in water
      Bubble Point at 23 °C≥4000 mbar (58 psig) air with water
      Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
      Maximum Differential PressureForward: 6900 mbar (100 psi) @ 25 °C; 1700 bar (25 psi) @ 80 °C; 340 mbar (5 psi) @ 135 °C. Reverse: 2100 mbar (30 psi) @ 25 °C, 69 mbar (1 psi) @ 135 °C
      Non-Fiber ReleasingThis product was manufactured with a Millipore Express® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
      TOC/ConductivityAfter sterilization and a controlled water flush of 20 L, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 °C.
      USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Cartridge Nominal Length10 in. (25 cm)
      Diameter6.9 cm (2.7 in.)
      Filtration Area0.49 m²
      Device Size10 in.
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • Polypropylene/Polysulfone
      Seal MaterialSilicone (SI)
      Support MaterialPolypropylene
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size3
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L
      Global Trade Item Number
      Catalog Number GTIN
      CHGE71TS3 04053252575389

      Documentation

      Material Qualification Dossier

      TitleVersion
      1.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Millipore Express® SHC Cartridge Filter 10 in. 0.5/0.2 µm Code 7 Silicone SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      DURAPORE CARTRIDGE C3NB64179
      Durapore Cartridge C1SB04547
      Durapore Cartridge C2SB42091
      Durapore Express SHC Cartridge C3BB79272
      Millipore Espress SHC Cartridge C3CB07384
      Millipore Express SHC Cartridge
      Millipore Express SHC Cartridge
      Millipore Express SHC Cartridge C9BA94694
      Millipore Express SHC Cartridge C0DB42331
      Millipore Express SHC Cartridge C2PB20635
      Show more

      Technical Info

      Title
      Extended bacterial retention testing of Millipore Express® 0.2 μm filters in a continuous flow system
      Steam-in-Place Method in the Reverse Direction for Millipore Express® PES Filters

      Data Sheet

      Title
      Millipore Express®SHC Hydrophilic Filters

      Posters

      Title
      Quality by Design (QbD) Principles in Aseptic Processing

      User Guides

      Title
      User Guide - Filters with Millipore Express®Membrane
      Vmax Constant Pressure